Double Blind Randomized Placebo-controlled Study in Children (<6mo) Comparing the Effects of Anti-thrombin III (ATIII) or Placebo on the Coagulation System in Infants With Known Low ATIII Levels Undergoing Open Congenital Cardiac Surgery

简要总结

详细描述

主要结局

次要结局

• Difference in the Mean and SD of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Times 5-Time 7 (ICU Arrival to Post Operative Day 4)(ICU arrival (Time 5) to Time 7 (Post-operative Day 4))
• Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7(T1, T2, T3, T5, T6 and T7)
• Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively(Baseline (Intraoperatively))
• Volume of Postoperative Blood Loss(From 10min post protamine administration to 24 hour post protamine administration)
• Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4(T4 (just prior to coming off of CPB))
• Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level.(T5 (Intensive Care Unit Arrival))
• Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group(Baseline (T1) to Post-Operative Day 4 (T7))
• Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7(T1, T5, T6 and T7)
• Total Dose of Heparin While on Cardiopulmonary Bypass(T1 (Baseline) to T5 (Arrival in ICU))
• Protamine Dose Determined by Hemostasis Management System Machine (mg/kg)(T1 (Baseline) to T5 (Arrival in ICU))
• Total Volume of Blood Products While on CPB(Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4))
• Time From Protamine Administration to Skin Dressing(Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4))
• Total Volume of Fresh Frozen Plasma Given Prior to CPB(Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4))
• Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters(protamine time plus 24 hours)
• Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group(24 Hours Post-Operatively)
• Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group(24 Hours Post-Operatively)
• Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively(Intraoperatively)
• Length of Post Operative Ventilation in Days(ICU arrival (Time 5) to Time 7 (Post-Operative Day 4))
• Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
• Incidence of Mediastinal Exploration Within 24 Hours Postoperatively(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
• Incidence (Number) of Thrombotic Events Documented(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
• Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
• Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))
• Length of Time to Delayed Sternal Closure Measured in Days(Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4))